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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06099561
Other study ID # Dnr 2023-01650-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date December 31, 2026

Study information

Verified date October 2023
Source Region Skane
Contact Magnus Nilsson, PhD
Phone 046-174925
Email magnus.per.nilsson@skane.se
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this project is to evaluate a novel treatment program for individuals with intractable and lethal self-harm. The main questions are: 1: Is there, in individuals with intractable self-harm, a relevant improvement in daily functioning and is this improvement related to the provided interventions? The secondary research questions are: 2. Is there, in individuals with intractable self-harm, a relevant improvement in frequency and severity of self-harm? 3. Is there, in individuals with intractable self-harm, a relevant improvement in voluntary hospital admissions? 4. Is there, in individuals with intractable self-harm, a relevant improvement in compulsary hospital admissions? 5. Is there, in individuals with intractable self-harm, a relevant improvement in the use of medication pro re nata? 6. Is there, in individuals with intractable self-harm, a relevant improvement in cost-effectiveness related to the provided interventions?


Description:

Individuals with intractable, imminent and lethal self-harm often have multifaceted psychiatric symptoms, pervasive suffering, high mortality and a reduced level of daily functioning. Severe self-harm can lead to long periods of psychiatric inpatient care which can lead to reduced autonomy and aggravated self-harm. Effects of this care remain uncertain. The Swedish National Board of Welfare has provided National specialized medical care units for severe self-harm behaviour to three Swedish hospitals. In one of this hospitals, Region Skåne, the intervention will be consultation-based. Individuals with intractable self-harm will be offered an assessment and review of all medical records which will result in a individualized intervention plan. Interventions include further assessments and supporting the existing treatment providers, families or caregivers. Recurring network-meetings will occur every three months as well as at he end of the intervention. Data collection will include self-report measures as well as information from charts and national och regional registries.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Having tried or made serious attempt to try at least two different interventions with evidence to reduce self-harm, without sufficient reduction in suffering or self-harm Exclusion Criteria: - Need for translation services to complete measures or interviews - Not able to complete measures or interviews

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
National specialized medical care unit for severe self-harm behaviour-Consultation model
Extensive assessments. Consultation and training for existing treatment providers and caregivers. Network-meetings for providers and caregivers.

Locations

Country Name City State
Sweden National Highly Specialized Unit for Self-Harm Behaviours, Skåne Lund Skåne

Sponsors (3)

Lead Sponsor Collaborator
Region Skane Department of Clinical Sciences, Malmö. Faculty of Medicine, Lund University., Department of Psychology. Lund University.

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary The World Health Organization Disability Assessment Schedule II (WHODAS 2.0) Level of daily functioning and disability in the domains of cognition, mobility, self-care, getting along with other people and life activities. Monthly from baseline to endpointat 24 months and at follow-up at 36 months.
Secondary Five Self-harm behaviour groupings measure (5S-HM) Indirect and direct self-harming behaviour Weekly from baseline to endpointat 24 months and at follow-up at 36 months.
Secondary The 5-level EQ-5D Quality of life scale Monthly from baseline to endpointat 24 months and at follow-up at 36 months.
Secondary Cost effectiveness Quantities and costs related to healthcare, municipal, social and rescue services. Monthly from baseline to endpointat 24 months and at follow-up at 36 months.
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